International Stem Cell Corporation
Completes Dosing of Second Cohort in Parkinson's Disease Clinical
Trial
Carlsbad, CA -- March 05, 2018 -- InvestorsHub
NewsWire -- International Stem Cell Corporation (OTCQB:ISCO),
a California-based clinical stage biotechnology company developing
stem cell-based therapies and biomedical products, announced today
that the eighth participant, which completes the dosing of the
second cohort of the clinical trial for Parkinson's disease, was
successfully transplanted with ISC-hpNSC® cells at the Royal Melbourne Hospital in
Melbourne, Australia.
ISCO’s Executive Vice President and Chief
Scientific Officer Russell Kern, PhD, commented, "We are pleased to
provide an update with the progress of our Parkinson’s disease
clinical trial. The completion of the second cohort of patients who
received 50 million ISC-hpNSC® cells, which represents a biologically active
dose in our preclinical studies, is a significant milestone for
ISCO. The data from the first cohort of our groundbreaking
therapy is already indicating safety and early signals of
efficacy.”
Recently,
ISCO announced its interim results of this clinical study at
the Society of Neurosciences Annual Meeting held in Washington DC.
The % OFF-Time, which refers to the time of day when levodopa
medication is not performing optimally and Parkinson’s disease
symptoms return, decreased an average of 24% for the first cohort
at six months post-transplantation. The % ON-Time without
dyskinesia, which refers to the time of day when levodopa
medication is performing optimally without dyskinesia, increased an
average of 19% for the first cohort during the same period. 100% of
the patients improved their mood six months post-transplantation
with an average improvement of 35% in the Beck Depression Inventory
and 33% in the Emotional Wellbeing dimension of the Parkinson's
Disease Quality of Life Score-39 (PDQ-39). 100% of patients
improved or retained the same cognitive abilities with an average
improvement of 14% in the Cognitive Impairment dimension of the
PDQ-39.
The introduction of levodopa more than 40 years ago
revolutionized the treatment of Parkinson's disease. While no drug
has been shown to slow the progression of the disease itself,
levodopa has proven to significantly reduce Parkinson’s disease symptoms with most
patients. However, there are no approved treatments that can fully
restore damaged dopaminergic neurons in the human brain. The death
of these neurons is what induces the motor symptoms most commonly
associated with Parkinson’s disease, including stiffness, slowness,
tremors and posture instability. Based on ISCO’s preclinical
research, ISC-hpNSC® has
the potential to provide neurotrophic support and neuroregeneration
to the affected tissues of the recipient brain.
ISC-hpNSC® is
the world's first pluripotent stem cell-based therapy for
Parkinson’s disease and if successful, it would represent a
paradigm shift in the treatment of this life-altering
disease.
About the clinical
study
The Phase I clinical study is a dose escalation
safety and preliminary efficacy study of ISC-hpNSC®, intracranially
transplanted into patients with moderate Parkinson's disease. The
open-label, single center, uncontrolled clinical trial will
evaluate three different dose regimens of 30,000,000 to 70,000,000
neural cells. A total of 12 participants with moderate-to-severe
Parkinson's disease will be treated. Following transplantation, the
patients will be monitored for 12 months at specified intervals to
evaluate the safety and biologic activity of ISC-hpNSC®. A PET scan
will be performed at baseline, as part of the screening assessment,
and at 6 and 12 months after surgical intervention. Clinical
responses compared to baseline after the administration of
ISC-hpNSC® will be evaluated using various neurological assessments
such as Unified Parkinson Disease Rating Scale (UPDRS), Hoehn and
Yahr and other rating scales. An extension phase of the study will
evaluate patients every 6 months for 5 additional years.
About Parkinson's
disease
Parkinson's disease is a degenerative
disorder of the central nervous system mainly affecting the motor
system. The motor symptoms of Parkinson's disease result from the
death of dopamine-generating cells in the substantia nigra, a
region of the midbrain. Early in the course of the disease, the
most obvious symptoms are movement-related. These symptoms include
shaking, rigidity, slowness of movement and difficulty with walking
and gait. Later, thinking and behavioral problems may arise, with
dementia commonly occurring in the advanced stages of the disease,
and depression as the most common psychiatric symptom. Parkinson's
disease is more common in people over the age of 50.
There are no approved treatments that
restore the damaged dopaminergic neurons. Medications typically
used in the treatment of Parkinson's disease, levodopa and dopamine
agonists, improve the early symptoms of the disease. As the disease
progresses and dopaminergic neurons continue to be lost, the drugs
eventually become ineffective, while at the same time frequently
producing a complication marked by involuntary writhing movements.
There are over 10 million people afflicted by Parkinson's disease
worldwide. In 2013 Parkinson's disease resulted in about 103,000
deaths globally, up from 44,000 deaths in
1990.
About ISC-hpNSC®
International Stem Cell Corporation's
proprietary ISC-hpNSC® consists of a highly pure population of
neural stem cells derived from human parthenogenetic stem cells.
ISC-hpNSC® is
a suspension of clinical grade cells manufactured under cGMP
conditions that have undergone stringent quality control measures
and are clear of any microbial and viral contaminants. Preclinical
studies in rodents and non-human primates have shown improvement in
Parkinson's disease symptoms and increase in brain dopamine levels
following the intracranial administration of
ISC-hpNSC®.
ISC-hpNSC® provides neurotrophic support and
neuroregeneration to the dying dopaminergic neurons of the
recipient Parkinson's disease brain. Additionally,
ISC-hpNSC® is
safe, well tolerated and does not cause adverse events such as
dyskinesia, systemic toxicity or tumors in preclinical models.
International Stem Cell Corporation believes that
ISC-hpNSC® may
have broad therapeutic applications for many neurological diseases
affecting the brain, the spinal cord and the
eye.
About International Stem Cell
Corporation
International Stem Cell Corporation
(ISCO) is focused on the therapeutic applications of human
parthenogenetic stem cells (hpSCs) and the development and
commercialization of cell-based research and cosmetic products.
ISCO's core technology, parthenogenesis, results in the creation of
pluripotent human stem cells from unfertilized oocytes (eggs).
hpSCs avoid ethical issues associated with the use or destruction
of viable human embryos. ISCO scientists have created the first
parthenogenetic, homozygous stem cell line that can be a source of
therapeutic cells for hundreds of millions of individuals of
differing genders, ages and racial background with minimal immune
rejection after transplantation. hpSCs offer the potential to
create the first true stem cell bank, UniStemCell™. ISCO also
produces and markets specialized cells and growth media for
therapeutic research worldwide through its subsidiary Lifeline Cell
Technology (www.lifelinecelltech.com), and stem cell-based skin
care products through its subsidiary Lifeline Skin Care
(www.lifelineskincare.com). More information is available
at www.internationalstemcell.com.
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developments, clinical studies expectations (including timing and
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opportunities for the company and its subsidiaries, along with
other statements about the future expectations, beliefs, goals,
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forward-looking statements. Any statements that are not historical
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such as "will," "believes," "plans," "anticipates," "expects,"
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maintenance of intellectual property rights. Actual results may
differ materially from the results anticipated in these
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with the many uncertainties that affect the company's business,
particularly those mentioned in the cautionary statements found in
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company disclaims any intent or obligation to update
forward-looking statements.
Contacts:
International Stem Cell
Corporation
Russell Kern, PhD
Executive Vice President
, Chief Scientific
Officer
Phone: +1 760 940 6383
Email:
ir@intlstemcell.com
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